Health Condition 1: null- Benign Prostatic Hyperplasia
Conditions
Interventions
Intervention1: Capsule Outflo (1 BD): Total duration of therapy 90 days.
Poly-herbal formulation containing
1. Boerhavia diffusa
2. Crateva nurvala
3. Tribulus terrestris
4. Curucma longa
5. Tinospora
Sponsors
Sahajanand Life Sciences Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: •Male patients with aged >=40 •New patients diagnosed with BPH, naïve to any other treatments for BPH •Patients with International Prostate Symptom Score (IPSS) greater than 7 and less than 18 •Patients with Prostate volume less than 40 cc •Patients with Qmax of 8-12 ml/sec •Patients with PVUR less than 200 ml •Patients willing to give written informed consent and willing to follow up
Exclusion criteria
Exclusion criteria: •Patients with prostatic cancer; neurogenic bladder; bladder cancer; bladder stones; urethral strictures; neurological conditions that might interfere with normal voiding •Symptomatic coronary arterial disease, stroke, and cardiovascular events •Current treatment with systemic corticosteroids or herbal (alternative) medicines •Patients with abnormal renal and hepatic function •Any significant disease or disorder that may jeopardize the safety of the subject •Patients with drug and alcohol abuse •Any psychiatric disorder •Patients who have participated in any clinical trial in the past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in International Prostate Symptom Score (IPSS) Change in Uroloflowmetry parametersTimepoint: Change in International Prostate Symptom Score (IPSS)(baseline - 1 month - 2 months - 3months) Change in Uroflowmetry parameters (baseline - 1 month - 2 months - 3months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Prostate VolumeTimepoint: Baseline - End of Study | — |
Countries
India
Contacts
Public ContactDr Nirav Joshi
Sahajanand Life Sciences Private Limited
Outcome results
None listed